Kornimate/medical-research-clean huggingface dataset:
d-dimer to select patients with first unprovoked venous thromboembolism who can have anticoagulants stopped at 3 months

Conditions: Deep Vein Thrombosis; Pulmonary Embolism

Summary: the purpose of this study is to determine if the risk of recurrent venous thromboembolism (vte) after stopping therapy is low and acceptable in patients with a first unprovoked proximal deep vein thrombosis (dvt) or pulmonary embolism (pe) who have completed 3 months of therapy and who have a negative d-dimer test on therapy and 1 month after stopping therapy.


Eligibility criteria:
inclusion criteria: 1. be \>= 18 years of age 2. have had one episode of unprovoked proximal dvt and/or pe 3. have completed 3 uninterrupted months of warfarin therapy (target inr of 2.0-3.0) exclusion criteria: 1. another indication for long-term anticoagulation (e.g., atrial fibrillation) 2. a high risk of bleeding as evidenced by any of the following: * age greater than 75 years * previous episode of major bleeding where the cause was not effectively treated * known chronic thrombocytopenia with a platelet count of less than 120,000 x 10\^9 /l * known chronic renal impairment with a creatinine of more than 150 mumols /litre (1.7 mg/dl) * known chronic liver disease with a total bilirubin of more than 25 mumols /litre (1.5 mg/dl) * active peptic ulcer disease * poor compliance with, or control of, anticoagulant therapy during initial treatment * requires dual antiplatelet therapy (e.g. aspirin and clopidogrel) 3. a vena caval filter 4. has had d-dimer testing performed within 2 months of potential enrollment other than for evaluation of suspected recurrent vte that was not confirmed 5. has a life expectancy less than 5 years 6. is unable to attend follow-up visits because of geographic inaccessibility 7. is participating in a competing clinical investigation

Keywords: unprovoked deep vein thrombosis unprovoked pulmonary embolism anticoagulant therapy
mucopolysaccharidosis (mps) i, ii, and vi screening in a high-risk population with previous surgical repair or presence of inguinal and/or umbilical hernia in combination with pediatric ent surgery (the hatt project)

Conditions: Mucopolysaccharidosis (MPS)

Summary: mucopolysaccharidosis (mps) type ii (mps ii; hunter syndrome) is a rare, x-linked disease caused by a deficiency of the lysosomal enzyme iduronate-2-sulfatase (i2s) and occurs almost exclusively in boys, with an incidence of approximately 1.3 per 100,000 live male births.1 early identification of mps ii is challenging because some initial features, such as chronic runny nose, otitis media, and hernias, are commonly seen in the general population. as a result, even though the signs and symptoms of mps ii typically appear early in childhood, the diagnosis may lag behind by several years. the primary objective of this international multi-center study is to evaluate the positive screening rate of mps ii subjects by screening a high-risk male pediatric population who have had or are scheduled for 1 or more specific ent surgical procedures (adenoidectomy and/or tonsillectomy and/or tympanostomy) and who have a previously repaired or present evidence of an inguinal and/or umbilical hernia.

with evidence-based information from mps registries regarding the types of surgical interventions that are most prevalent in mps, this screening study is expected to provide the understanding of the role pediatric ent surgeons can play in identifying young children with mps.

Eligibility criteria:
inclusion criteria: each subject must meet the following criteria to be enrolled in this study: 1. the subject is male. 2. the subject is \<7 years of age. 3. the subject has had or is scheduled for ent surgery for any of the following, alone or in combination: adenoidectomy, tonsillectomy, and tympanostomy. 4. the subject has record of previous surgical repair or presence of inguinal and/or umbilical hernia. 5. the subject's parent(s) or the subject's legally authorized representative(s) has provided written informed consent that has been approved by the institutional review board/independent ethics committee (irb/iec). exclusion criteria: subjects who meet any of the following criteria will be excluded from the study: 1. the subject has a current confirmed diagnosis of any mps disorder. 2. the subject was born prematurely (defined as born before 37 weeks gestation). 3. the subject has received a blood transfusion within the past 6 weeks. 4. the subject has received a bone marrow transplant.

Keywords: mps ii iduronate-2-sulfatase mucopolysaccharidosis vi mps mps vi ear, nose and throat mucopolysaccharidosis ii hunter syndrome ent mucopolysaccharidosis i hurler, hurler-scheie, or scheie syndrome mucopolysaccharidosis mps i maroteaux-lamy syndrome
effect of d-amphetamine on reward functioning

Conditions: Anhedonia

Summary: the purpose of this study is to establish the dose-response curve for therapeutic doses of d-amphetamine on tasks of motivation and reward learning in the same participants and to use d-amphetamine as a dopaminergic probe to test newer theories about the role of dopamine in reward-related decision-making.


Eligibility criteria:
inclusion criteria: - healthy individuals exclusion criteria: * individuals with a body mass index (bmi) \ 26, as this alters dosing requirements * individuals with high blood pressure, abnormal electrocardiography (ekg), any medical condition requiring regular medication (except birth control), any other regular use of a drug or supplement with potentially hazardous interactions with d-amphetamine (e.g. st. john's wort), or any other medical contraindication to amphetamine administration as determined by our study physician * individuals who report no prior experience with recreational drugs of any kind (including alcohol), or who report a previous adverse reaction to amphetamine * individuals with a current diagnostic and statistical manual of mental disorders-v (dsm-v) axis i diagnosis, excluding mild substance use disorders (≤ 3 symptoms) * individuals with a lifetime history of moderate to severe substance use disorder (≥ 4 symptoms), mania or psychosis. * women who are pregnant. * individuals smoking more than 10 cigarettes per week will also be excluded, to avoid confounding the effects of nicotine withdrawal with the effects of the study drugs/procedures, as participants will not be allowed to smoke during the sessions. * individuals with less than a high-school level of education or fluency in english will be excluded as our questionnaires require high-school level fluency in english, and have not been translated and validated in other languages.

Keywords: reward learning decision making
efficacy study of nifedipine controlled-release tablets (xin ran) to treat early morning blood pressure and central arterial pressure

Conditions: Essential Hypertension

Summary: the purpose of this study is to compare nifedipine controlled-release (cr) tablets (xin ran) with nifedipine controlled-release tablets (adalat）in the treatment of early morning blood pressure and central arterial pressure.


Eligibility criteria:
inclusion criteria: * voluntarily participate and must sign informed consent form * mild to moderate essential hypertension (sbp 140-179 mmhg and/or dbp 90-109 mmhg) * the mean morning blood press of one week \>135/85 mmhg exclusion criteria: * secondary hypertension and malignant hypertension * pregnant or nursing women, or patients that cannot guarantee to take effective contraception measures * baseline sbp≥180 mmhg or dbp≥110 mmhg, or patients with cerebral, cardiac or renal complications * have following complications: cerebrovascular accident within 6 months, myocardial infarction or cardiac failure, macroaneurysm or dissecting aneurysm, definite angina, a-v block of grade 2 or higher, sick sinus syndrome, atrial fibrillation or other malignant arrhythmia * clinical significant diseases of heart, lung, liver, kidney and hematologic system or malignant tumors, hiv infection, uncontrolled diabetes (fasting blood glucose ≥7.0 mmol/l, 2-hour postprandial blood glucose ≥7.8 mmol/l) * kock pouch * sever gastrointestinal stenosis * abnormal laboratory values with clinical significance, including serum potassium \ 5.5 mmol/l, glutamic-pyruvic transaminase (alt) or glutamic oxalacetic transaminase (ast) \>2-fold upper limit of normal (uln), cr \>uln * gastrointestinal abnormalities or surgery that may interfere with drug absorption * hyperthyroidism or hypothyroidism * allergic to any ingredient or metabolite of investigational drug or drugs of similar structure * psychological diseases, acrasia, cannot express explicitly * patients whose mood may be affected by variations in blood pressure, which in turn increases blood pressure * anxiety disorders, depression or cannot follow study protocol * bmi \>30 * night shift, irregular sleep patterns or insomnia * participate in other clinical trials within 3 months * other conditions that investigators consider unsuitable for participation
clinical study to explore the efficacy of act-129968 in patients with partly controlled asthma

Conditions: Asthma

Summary: this study will assess the efficacy and safety of act-129968 in subjects with partly controlled asthma on reliever therapy only.


Eligibility criteria:
inclusion criteria: * signed informed consent prior to any study-mandated procedure * males and females age 18 to 65 years * women of childbearing potential must use adequate contraception * presenting with a diagnosis of asthma according to gina guidelines * pre-bronchodilator forced expiratory volume in one second (fev1) \< / = 85% of patient's predicted normal value * reversibility of airway obstruction of \> / = 12% and \> / = 200ml from pre-bronchodilator fev1 * acq score \> / = 1.5 exclusion criteria: * history of life-threatening asthma * any asthma exacerbation requiring treatment with systemic corticosteroids within the last 3 months * ongoing or recent treatment with medication for allergic airway disease * smoking within the last year, or life-time consumption \> / = 10 pack-years (e.g., 20 cigarettes/day for 10 years) * history of chronic pulmonary disease (other than asthma), such as chronic obstructive pulmonary disease (copd), fibrosis, tuberculosis or sarcoidosis * pregnant or lactating women * diagnosis of aspirin or non-steroidal anti-inflammatory drug (nsaid)-induced asthma * any hospital admission for asthma within the last 6 months * anti-ige therapy at any time check/update interventions by explicitely writing the experimental drug dosage in the interventions description * any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
bioequivalence study of torrent pharmaceuticals ltd's clopidogrel tablets under fed condition

Conditions: Healthy

Summary: objective: primary objective of the present study was to compare the single dose bioavailability of torrent's clopidogrel tablets usp 1 × 75 mg and plavix® (clopidogrel bisulfate) tablets 1 × 75 mg of bristol-myers squibb/sanofi pharmaceuticals, usa. dosing periods were separated by a washout period of 7 days. study design: open-label, randomised, two period, two treatment, crossover, single-dose bioequivalence study


Eligibility criteria:
inclusion criteria: the volunteers were included in the study based on the following criteria: * sex: male. * age: 18 - 45 years. * volunteer with bmi of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight. * healthy and willing to participate in the study. * volunteer willing to adhere to the protocol requirements and to provide written informed consent. * non-smokers or smoker who smokes less than 10 cigarettes per day exclusion criteria: the volunteers were excluded from the study based on the following criteria: * clinically relevant abnormalities in the results of the laboratory screening evaluation. * clinically significant abnormal ecg or chest x-ray. systolic blood pressure less than 100 mm hg or more than 140 mm hg and diastolic blood pressure less than 60 mm hg or more than 90 mm hg. * pulse rate less than 50/minute or more than 100/minute. oral temperature less than 95°p or more than 98.6°p. respiratory rate less than 12/minute or more than 20/minute history of allergy to the test drug or any drug chemically similar to the drug under investigation. * history of alcohol or drug abuse positive breath alcohol test recent history of kidney or liver dysfunction. history of consumption of prescribed medication since last 14 days or otc medication since last 07 days before beginning of the study. * volunteers suffering from any chronic illness such as arthritis, asthma etc. history of heart failure. hiv, hcv, hbsag positive volunteers. opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - - - cocaine positive volunteers based on urine test. * volunteers suffering from any psychiatric (acute or chronic) illness requiring medications. * administration of any study drug in the period 0 to 3 months before entry to the study. * history of significant blood loss due to any reason, including blood donation in the past 3 months. * history of pre-existing bleeding disorder. existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers. * inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
trial to reduce cardiovascular events with aranesp® therapy (treat)

Conditions: Kidney Disease; Diabetes Mellitus; Anemia

Summary: the purpose of this study is to assess the impact of treatment of anemia with darbepoetin alfa to a hemoglobin target of 13 g/dl on (1) all-cause mortality and nonfatal cardiovascular events, and (2) progression to end-stage renal disease or death, in subjects with chronic kidney disease and type 2 diabetes mellitus. academic pi/executive committee chairman: marc pfeffer, md, phd


Eligibility criteria:
inclusion criteria: * hemoglobin less than or equal to 11 g/dl * history of chronic kidney disease * egfr (estimated glomerular filtration rate) greater than or equal to 20 ml/min/1.73 m2 and less than or equal to 60 ml/min/1.73 m2 * tsat (transferrin saturation) greater than 15% exclusion criteria: * uncontrolled hypertension * erythropoietic protein use within 12 weeks of randomization
rg2133 (2',3',5'-tri-o-acetyluridine) in mitochondrial disease

Conditions: Mitochondrial Diseases

Summary: the objective of the study is to determine the safety and tolerability of rg2133 in patients with mitochondrial disease.


Eligibility criteria:
mitochondrial disease
effect of roflumilast on exacerbation rate in patients with chronic obstructive pulmonary disease (copd): the hermes study (by217/m2-125)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the aim of the study is to compare the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (copd). roflumilast will be administered orally once daily in the morning at one dose level. the study duration will be up to 56 weeks. the study will provide further data on safety and tolerability of roflumilast. for additional information (for us patients only) see www.copdstudy.net or dial 866-788-2673 (toll free).


Eligibility criteria:
main inclusion criteria: * copd patients having at least one exacerbation within last year * fev1/fvc ratio (post-bronchodilator) ≤ 70% * fev1 (post-bronchodilator) ≤ 50% of predicted main exclusion criteria: * copd exacerbation not resolved at first baseline visit * diagnosis of asthma and/or other relevant lung disease

Keywords: roflumilast copd chronic obstructive pulmonary disease
the role of nk cells to detect blood infection in all.

Conditions: Acute Lymphoblastic Leukemia; Bloodstream Infection

Summary: 1. assess possibility of prediction of blood stream infections in all patients by profiling of nk cells using flow cytometry. 2. assess the role of nk cells in development of drug resistance post chemotherapy.

acute lymphoblastic leukemia (all) is the most common malignancy affecting children accounting for approximately 30% of childhood cancers (zeng xl et al, 2023 all is characterized by chromosomal abnormalities and genetic alterations involved in the differentiation and proliferation of lymphoid precursor cells (fujita, sousa-pereira et al. 2021). all is categorized in b-lymphoblastic leukemia (b-all) and t-lymphoblastic leukemia (t-all), originated from b- and t-lineage lymphoid precursor cells, respectively (chiaretti s et al, 2014). recent progress in treatment of all has increased the survival rate significantly. the 5-year survival rate in children with all is approximately 90% (paul 2016). bloodstream infection is a major cause of treatment-related morbidity and mortality in pediatric patients treated for acute lymphoblastic leukemia (wolf, tang et al. 2017). this is caused by severe and prolonged immunosuppression due to neutropenia, and other chemotherapy-induced alterations of host defense mechanisms the rise of multidrug-resistant bacteria has generated a great challenge to treat infections caused by bacteria with the available antibiotics one of the crucial first line of defense against bloodstream infections in the immune system are natural killer cells natural killer (nk) cells are lymphocytes of the innate immune system that are critical in host defense and immune regulation they can mediate spontaneous cytotoxicity towards malignant cells and microbes, and rapidly secrete numerous cytokines and chemokines to promote subsequent adaptive immune responses nk cells can be subdivided into different populations based on the relative expression of the surface markers cd16 and cd56

Eligibility criteria:
inclusion criteria: * patients aged less than 17 years diagnosed as acute lymphoblastic leukemia and on chemotherapy, who are positive for blood stream infection. exclusion criteria: 1. patients over 17 years of age. 2. presence of other hematological malignancies or history of other malignancies.

Keywords: natural killed cells
dynamic light scattering device (dls) study of age-related changes in the lens and cataracts

Conditions: Cataract; Healthy

Summary: this study will use a newly developed instrument called dynamic light scattering device (dls) to examine age-related changes in the human lens and to study the causes and development of cataracts. dls uses a low intensity laser light (similar to that used in supermarket checkouts) to measures lens cloudiness. it detects changes in the human lens at the earliest stages, when anti-cataract treatment would be most effective in reversing, delaying or preventing cataract formation. patients 18 years of age and older with cataracts and normal volunteers between the ages of 18 and 70 years may be eligible for this study. participants will have a standard eye examination, including a vision check, pressure measurement, lens examination using dls and examination of the retina. photographs of the lens or retina, or both, may be taken. this study does not involve treatment. no anti-cataract medications will be given.

recently, a device has been created to determine molecular interactions that occur in the nucleus of the lens, called dynamic light scattering device (dls). preliminary studies have shown its potential in the detection of the earliest changes occurring in cataract, at the stage where anticataract treatment would theoretically be most effective in reversing, delaying or preventing cataracts. a new miniaturized version of this device has been developed by nasa using lower energy lasers and offered for further development and testing at the nei. we recently conducted a pilot study to evaluate the usefulness and reproducibility of this instrument for quantitating lens changes, and found good reproducibility. we also determined that the most useful parameter to use is mean particle size derived from particle size distribution. we therefore propose to conduct a study on changes on the lens due to aging (age related changes), as well as on the three representative types of cataracts (nuclear, cortical and psc).

Eligibility criteria:
inclusion: patients 18 years or older will be admitted to this study. there will be no gender or sex bias in the recruitment. fifteen subjects (30 eyes) who are normal volunteers of either sex, 3 for each decade from 18-70, will be recruited. these normal volunteers should have clear lenses with locs ii clinical score for nuclear opalescence of 0.5 or less. three patients (18 eyes) for each major type of cataract (nuclear, cortical and psc), will be recruited also for evaluation with the dls device. all 3 types of cataracts will be graded using the locs ii system and will have a clinical score of at least one. exclusion: patients who have uveitis, glaucoma and who are thought to be at risk for an adverse reaction to pupil dilation, or have a history of allergic reaction to one of the dilating agents that will be used.

Keywords: cataract early lens changes protein aggregation blindness vision dynamic laser scattering (dls) age-related changes test re-test reproducibility normal volunteers lens healthy volunteer
cross correlation of pain hypersensitivity and clinical features and electromyography in low back pain patients

Conditions: Low Back Pain

Summary: diagnostic and prognostic value of pain hypersensitivity in low back pain (lbp) is not fully understood.increased pain sensitivity in the primary area of pain (local pain) is considered a sign of predominantly peripheral pain sensitization,value of pain hypersensitivity in low back pain (lbp)is not fully understood whereas pain sensitivity in distal and remote areas is considered to present a more central phenomenon. it is suggested that pat ents with enhanced pain sensitivity report high level of disability. despite fact that pain and disability are associated in chronic lbp the exact mechanisms of sensitivity contribution in lbp disability is unknown. it has also been suggested that muscle function changes may be driven by pain. the possible role and contribution of trunk muscles function to pain and disability phenomena remain unknown. this study was aimed to estimate prevalence and possible correlation among pain hypersensitivity and functional and electromyography parameters of trunk muscles in patients reporting early phase of chronic lbp.


Eligibility criteria:
inclusion criteria: * low back pain for at least 12 weeks * magnetic resonance imaging (mri) confirmation of prolapsed intervertebral disc (pid) * no meeting excluding criteria. exclusion criteria: * no response to initial contact * red flag symptoms * diabetes mellitus, * neurological problems and * cancer * pregnant patients * patients treated chirurgically for the same problem or treated with oral corticosteroids and steroid injections for any reason in the previous month.